HPRA and Implementation of the Regulations

Implementation at national level

The HPRA is in the process of drafting a detailed implementation plan for the two Regulations.

We will continue to work closely with the Department of Health (DoH) to ensure that the Regulations are implemented effectively and that the legal, resource and system requirements are all put in place at national level.

A central component to this implementation plan is engagement with relevant stakeholders to clearly communicate the requirements of these new Regulations to ensure they are correctly understood and implemented on time.

The HPRA is committed to working closely with affected stakeholders on implementation and will continue our regular dialogue with the industry and trade associations in Ireland.

We encourage engagement from all stakeholders on the new legislative requirements.

We have a dedicated mailbox to queries relating to the implementation of the medical devices and in vitro diagnostic medical device regulations.

For implementation queries please email us at mdr-ivdrqueries@hpra.ie 

While we may not be able to address every individual query received it is a mechanism to collate issues and identify the need for guidance or clarification on specific aspects of the regulations which we may do through our website or guidance at national or EU level.’

Planned future stakeholder events will be published in the News and Events section of our website during the implementation phase.